KS P ISO 10555-5-2007 Sterile single-use intravascular catheters-Part 5:Over-needle peripheral catheters《一次性无菌血管内导管 第5部分 与针头相连的辅助导管》.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 10555 5 , 5: KS P ISO 10555 5: 2007(2012 ) 2007 11 30 http:/www.kats.go.krKS P ISO 10555 5: 2007 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) : :2002 12 17 :2007 11 30 :2012 12 6 : 20120679 : ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO

2、 10555 5: 2007 i 1 1 2 1 3 .1 4 3 4.1 .3 4.2 -(radio -detectability) 3 4.3 (multilumen) 3 4.4 .3 4.5 .4 A( ) 5 A.1 .5 A.2 5 A.3 5 A.4 5 B( ) 6 B.1 .6 B.2 .6 B.3 6 B.4 6 B.5 .6 B.6 6 C( ) .8 D( ) 9 E( ) 10 E.1 .10 E.2 10 E.3 10 E.4 10 E.5 10 F( ) 12 .13 KS P ISO 10555 5: 2007 (2012 ) , 5: Sterile, si

3、ngle-use intravascular catheters Part 5: Over-needle peripheral catheters 1996 1 , 1999 1 2002 (2002 6 15 ) ISO 10555 5, Sterile, single-use intravascular catheters Part 5: Over-needle peripheral catheters , . 1 , . ISO 11070 obturators ISO 14972 . 2 . . ( ) . KS P ISO 10555 1, , 1: ISO 594 1: 1986,

4、 Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements ISO 9626: 1991, Stainless steel needle tubing for the manufacture of medical devices 3 KS P ISO 10555 1 . 3.1 (peripheral intravascular catheter) , 3.2 (needle) KS P ISO 10

5、555 5: 2007 2 1 ( 1 ) 3.3 (needle tube) 3.4 (needle hub) . 3.5 (vent fitting) , . 3.6 (catheter unit) , ( 1 ) 3.7 (flashback) a 4.4.2 ; 0 a 1 mm l1 1 2 3 4 5 6 (heel of bevel) 7 , , , . . 1 KS P ISO 10555 5: 2007 3 4 4.1 , KS P ISO 10555 1 . 4.2 - (radio-detectability) . 4.3 (multilumen) . 4.4 4.4.1

6、 1 . 4.4.2 , . , 1 mm ( 1 a ). 4.4.3 4.4.3.1 . , ISO 9626 . . 1 mm mm a,bc0.6 0.7 0.8; 0.9 1.0; 1.1 1.2; 1.3 1.4; 1.5 1.6; 1.7; 1.8 1.9; 2.0; 2.1; 2.2 2.3; 2.4; 2.5 2.6; 2.7; 2.8 3.3; 3.4 0.550 0.649 0.650 0.749 0.750 0.949 0.950 1.149 1.150 1.349 1.350 1.549 1.550 1.849 1.850 2.249 2.250 2.549 2.55

7、0 2.849 3.250 3.549 26 24 22 20 18 17 16 14 13 12 10 a , . (color references) C . b . c . KS P ISO 10555 5: 2007 4 4.4.3.2 (needle point) 2.5 , , . . D . 4.4.3.3 , . , ISO 594 1 6 %( ) . 4.4.3.4 A , . 4.4.4 . 4.4.5 B , 1.0 mm 80 % 125 % . 1.0 mm 90 % 115 % . 4.5 KS P ISO 10555 1 , . a) b) c) , . . K

8、S P ISO 10555 5: 2007 5 A ( ) A.1 . A.2 A.2.1 1 % 20 N . A.3 A.3.1 40 % 60 % (222) 2 . A.3.2 . 100 mm/min . 0.6 mm 10 N 0.6 mm 20 N A.3.3 . A.4 . a) b) c) ( , 10 N 20 N) d) KS P ISO 10555 5: 2007 6 B ( ) B.1 . B.2 B.3 B.3.1 ISO 594 1 6 %( ) , , (52525) mL/min , (1 0005) mm . B.1 . B.3.2 1 % . B.3.3

9、 B.4 B.4.1 (B.3.1) (222) . 6 %( ) . B.4.2 . (30 ) . . , 1 000 kg/m3 . B.4.3 3 . B.5 3 . 1 mL/min . B.6 KS P ISO 10555 5: 2007 7 . a) b) 1 mL/min : mm 1 2 3 4 5 6 6 %( ) 7 8 / B.1 KS P ISO 10555 5: 2007 8 C ( ) C.1 . C.1 mm Munsell Atlasa 595abDIN 61641cNF X08002d0.6 5 P 6.5/6 A 2790 0.7 3.75 Y 8/14

10、 23 655 1.9; 6.8; 0.7 A 330 0.8; 0.9 2.5 PB 3/8 15 090 16.6; 6.5; 4.2 A 540 1.0; 1.1 2.5 R 7/6 11 630 8.5; 1.4; 1.5 A 870 1.2; 1.3 2.5 G 4/8 14 090 22.6; 6.9; 5.0 A 455 1.4; 1.5 N 9.5 27 875 1.0; 0.4; 0.3 A 665 1.6; 1.7; 1.8 N 7 26 231 24.4; 0.2; 3.9 A 630 1.9; 2.0; 2.1; 2.2 3.75 YT 6/12 12 473 4.5;

11、 6.6; 1.7 A 130 2.3; 2.4; 2.5 7.5 R 4/14 7.4; 7.9; 2.7 A 801 2.6; 2.7; 2.8 2.5 PB 7/8 35 190 17.5; 4.4; 2.0 A 590 3.3; 3.4 7.5 YR 4.5/6 A 2030 aMunsell Book of Color. Available from Munsell Color, 2441 N. Calvert Street, Baltimore, MD 21218 USA bUS Federal Standard 595a; Colors, Volume 1. Available

12、from Superintendent of Documents, US Government Printing Office, Washington DC, 20402 USA cGerman Standard DIN 6164 1, DIN Farbenkarte; System der DIN Farbenkarte fr den 2 Normalbeobachter. Available from Beuth Verlag GmbH, Burggrafenstrasse 6, D 10787 Berlin, Germany dFrench Standard NF X 08 002, C

13、ollection rduite des couleurs Dsignation et catalogue des couleurs CCR talons secondaires(Limited collection of colours. Designation and catalogue of CCR colours. Secondary standards.) Available from AFNOR, Tour Europe, Cedex 7, F 92080 Paris La Dfense, France KS P ISO 10555 5: 2007 9 D ( ) D.1 . do

14、 l1 1 di l2 2 2 2 l 1 2 D.1 do di 2 A A B B A A B B l1l2l1l2l do dil KS P ISO 10555 5: 2007 10 E ( ) E.1 . . E.2 E.2.1 9 g 1 L 0.9 %(M/V) . E.2.2 (E.2.1) 550 mL USP 450 mL . , . E.3 E.3.1 (40020) mm ( , ) , 3 mm . E.1 . E.3.2 E.4 E.4.1 (E.3.1) (232) (E.2) . E.4.2 . E.4.3 . 5 . E.4.4 . . E.5 . a) KS

15、P ISO 10555 5: 2007 11 b) : mm 1 2 3 4 5 6 7 (membrane) 8 9 E.1 KS P ISO 10555 5: 2007 12 F ( ) 1 ISO 11070: 1998, Sterile, single-use intravascular catheter introducers 2 ISO 14972: 1998, Sterile, obturators for single-use with over-needle peripheral intravascular catheters KS P ISO 10555 5: 2007 1

16、3 KS P ISO 10555 5: 2007 1 1.1 , . , , , 21 , . . , , . , . , , . 1.2 . 1.3 ISO 10555 5 KS . 2 , (over-needle peripheral catheters) . 3 3.1 , . 3.2 , , , , KS P ISO 10555 5: 2007 14 . 3.3 , , , . , 5: 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 10555 5: 2007KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Sterile, single-use intravascular cathetersPart 5:Over-needle peripheral catheters ICS 11.040.20

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